Clinical Impact of Patient-ventilator Asynchrony

NCT05796297 | Completed

• 1 other identifier: RC23_0099
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation.

Conditions

Chronic Respiratory Failure; Non-invasive Ventilation; Asynchrony Between Patient and Ventilator; Efficacy and Tolerance of Non-invasive Ventilation; Clinical Repercussions of the Various Patient-ventilator Asynchronies

Keywords

Tolerance; Efficiency; Patient ventilator asynchrony; NIV

Outcome Measures

Primary Outcomes (1)

• Ventilation's efficiency/tolerance

  Presence of a significant rate of patient-ventilator asynchrony when reading the ventilation curves of the NIV machine data.

  Up to 14 days

Secondary Outcomes (2)

• Estimation of quality of life with non-invasive ventilation

  Up to 14 days

• Estimation of quality of sleep with non-invasive ventilation

  Up to 14 days

Study Arms (2)

Patient with significant patient ventilator asynchrony

Active Comparator

Device: Transcutaneous Capnography

Patient without significant patient ventilator asynchrony

Active Comparator

Device: Transcutaneous Capnography

Interventions

Transcutaneous Capnography DEVICE

Transcutaneous Capnography will be realized at patient home to monitoring nocturnal concentration of carbon dioxide during nocturnal sleeping ventilation

Patient with significant patient ventilator asynchrony; Patient without significant patient ventilator asynchrony

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with chronic respiratory insufficiency fitted with long-term NIV, whatever the reason for the chronic respiratory insufficiency. A transcutaneous capnography within 15 days preceding the follow-up consultation and obtaining the SIM card containing the machine data will be required to be included in the study.

You may qualify if:

• Women and Men aged of at least 18 years old.
• NIV equipment since 6 months ( at least)
• Chronic respiratory failure requiring NIV equipment defined by clinical symptoms (asthenia, excessive daytime sleepiness, headache, dyspnea) and:
• In case of obstructive diseases :
• Daytime hypercapnia (PaCO2 \> 55 mmHg) or Daytime hypercapnia between 50-54 mmHg associated with nocturnal desaturations (at least 5 min below 88% saturation) or episodes of frequent hypercapnic exacerbations (at least 2 over the last 12 months)
• In case of restrictive diseases :
• Daytime hypercapnia (PaCO2\>6 kPa (kilopascal) or 45 mm Hg) or Nocturnal desaturation (SaO2 \< 88%) for at least 5 minutes without obstructive sleep apnea syndrome (OSAS) found or Marker of progression of neuromuscular damage (Maximum inspiratory pressure \< 60 cm H2O and forced vital capacity (FVC) less than 50% of theory)
• NIV's start from at least 6 months.
• Patient who did not object to being included in the study.
• Patient in stable condition without exacerbation (for at least 3 months)

You may not qualify if:

• Minor patient
• Pregnant or breastfeeding women
• Adult patient subject to enhanced protection, deprived of liberty by judicial or administrative decision.
• Patient who is physically or psychologically unable to follow the protocol in an informed manner.
• Patient with chronic respiratory failure requiring mechanical ventilation by tracheotomy
• Patient having changed center or service provider (data not available).
• Patient who objected to being included in the study

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JAFFRE, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: June 1, 2023
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

FR (1)